Effectiveness of Preoperative Surgical Scrubbing Using Clorhexidine Digluconate and Parachlorometaxylenol (ECP)

Not Applicable

Completed

• Conditions: Skin Diseases; Surgical Site Infection
• Interventions: Procedure: Preparatory handwash; Procedure: Preoperative surgical scrubbing using 3% PCMX; Procedure: Preoperative surgical scrubbing using 4% CHG

• Registration Number: NCT02500758
• Lead Sponsor: Ricardo Becerro de Bengoa Vallejo

Brief Summary

Despite the wide variety of products and antiseptic agents, no agent is ideal for every situation. The investigators would like to evaluate the difference in reducing bacterial load, using 4% chlorhexidine digluconate and 3% parachlorometaxylenol after a preoperative surgical scrubbing.

Detailed Description

The investigators conducted a controlled, prospective, randomized study to evaluate the antiseptic effectiveness of preoperative surgical scrubbing using 4% chlorhexidine digluconate and 3% parachlorometaxylenol. Samples were taken from the hands of each volunteer after a preparatory handwash, pre-surgical scrubbing, post-surgical scrubbing and 3 hours after surgical scrubbing.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-20
• Primary Completion: 2015-07
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-16
• Study Completion: 2016-01
• Results First Submitted: 2016-01-04
• Results First Submitted QC: 2017-01-30
• Results First Posted: 2017-03-21
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• No systemic diseases.
• Healthy skin on hands, without cuts or abrasions.
• Short and clean fingernails.
• No use of substances with antimicrobial action (e.g. medicated soaps or creams).

Exclusion Criteria

• History of eczema.
• History of psoriasis.
• Allergies to any of the ingredients of the solutions or contraindication to its use.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Clorhexidine digluconate	Preparatory handwash	Reducing bacterial load after preoperative surgical scrubbing using 4% CHG. Both hands have been prepared by preparatory handwash.
Parachlorometaxylenol	Preoperative surgical scrubbing using 3% PCMX	Reducing bacterial load after preoperative surgical scrubbing using 3% PCMX. Both hands have been prepared by preparatory handwash.
Clorhexidine digluconate	Preoperative surgical scrubbing using 4% CHG	Reducing bacterial load after preoperative surgical scrubbing using 4% CHG. Both hands have been prepared by preparatory handwash.
Parachlorometaxylenol	Preparatory handwash	Reducing bacterial load after preoperative surgical scrubbing using 3% PCMX. Both hands have been prepared by preparatory handwash.

Primary Outcome Measures

Name	Time	Method
Change in the Release of Skin Flora From the Hands From Baseline to 5 Minutes After Disinfection by Surgical Scrubbing (Time Frame- "Baseline and 5 Minutes").	5 minutes	Number of colony-forming units (CFU) sampled up to 5 minutes after disinfection by surgical scrubbing using parachlorometaxylenol or clorhexidine digluconate. After surgical scrubbing and drying, the fingertips are rubbed (including that of the thumb) for 1 minute on the base of a Petri dish containing volumes of 1.0 ml and 0.1 ml of undiluted sampling fluid of TSB and 0.1 ml from its 10-1 dilution are plated out for quantitative culture in TSA.

Secondary Outcome Measures

Name	Time	Method
Change in the Release of Skin Flora From the Hands From Baseline to 3 Hours After Surgical Scrub Disinfection, Wearing Surgical Gloves (Time Frame- "Baseline and 3 Hours").	3 hours	Number of colony-forming units (CFU) sampled 3 hours after disinfection by surgical scrubbing using parachlorometaxylenol or clorhexidine digluconate, using surgical gloves. After surgical scrubbing, drying and wearing surgical gloves, the fingertips are rubbed (including that of the thumb) for 1 minute on the base of a Petri dish containing volumes of 1.0 ml and 0.1 ml of undiluted sampling fluid of TSB and 0.1 ml from its 10-1 dilution are plated out for quantitative culture in TSA.